1. Field of the Invention
The present invention is directed to a pharmaceutical composition in the form of capsules, tablets, creams, foams, ointments, powders, suppositories or the like containing micro-encapsulated lactobacilli for oral, topical and intra-vaginal administration for the treatment or prevention of antibiotic associated diarrhea, skin and vaginal infections.
2. Brief Description of the Prior Art
Antibiotic associated diarrhea is a common side effect of broad spectrum anti-bacterial therapy, and is believed to be due to a shift in intestinal flora as a result of therapy with antibiotics, and particularly due to loss of lactobacilli in the intestinal flora. This condition can become life-threatening to the patient and is very difficult to treat when it is caused by a Clostridium difficile bacterial infection.
It has been attempted in the prior art to treat antibiotic associated diarrhea with oral administration of lactobacilli. This type of therapy, however, has been proven to be of only limited success, for two primary reasons. First, orally administered lactobacilli, in accordance with the prior art, are exposed to the destructive action of gastric acid. Therefore only an inadequately small number of viable lactobacilli tend to reach the lower intestinal tract where they would be needed to reestablish a healthy lactobacilli flora. Second, transient lactose intolerance is frequently found in persons suffering from antibiotic associated diarrhea. (The temporary lactose intolerance is attributed by those skilled in the art to the loss of the brush border of the intestinal villa, caused by the antibiotic.) Moreover, this type of transient lactose intolerance frequently occurs even in persons who, otherwise under normal conditions, have no prior history of dairy product or lactose intolerance. Lactobacilli preparations in accordance with the prior art usually contain traces or remnants of the media in which the lactobacilli bacteria were grown and therefore contain lactose, lactulose and other disacharides. These in turn, upon reaching the lower intestines of persons suffering from antibiotic associated diarrhea, tend to make worse the transient lactose intolerance condition. In light of the foregoing, there is room for improvement in the prior art. More particularly, there is room in the prior art for improvement of pharmaceutical compositions and methods for the treatment of antibiotic associated diarrhea, and also for treatment or prevention of certain skin and vaginal infections. The present inventions provides such improvements.